US Regulatory Affairs 2014

  • 05-07 Nov 2014
  • Holiday Inn London Bloomsbury, United Kingdom

Description

US Regulatory Affairs 2014 is a course that covers topics such as:

  • The basics Overview of the FDA Regulatory requirements for drug development and approval
  • Regulation of drugs and biologics:
  • The IND - In detail
  • The IND - A general introduction
  • Procedures for reporting Adverse Events (AEs) that occur during clinical investigations
  • IND Amendments and maintenance
  • Post-approval regulatory requirements for NDAs Interactions with FDA
  • Submitting the NDA in CTD format – What’s unique to FDA
  • Regulatory compliance and FDA Inspections: What to expect after submitting the NDA
  • US regulatory requirements for advertising and labelling
  • Navigating the FDA on the interne

US Regulatory Affairs 2014 is intended for industry auditors and regulatory authority inspectors.

Past Events

Important

Please, check "US Regulatory Affairs" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Pharma

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